Statements (56)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:standard
|
| gptkbp:bfsLayer |
7
|
| gptkbp:bfsParent |
gptkb:IEC_60601_series
|
| gptkbp:addresses |
user interface design
|
| gptkbp:aims_to |
ensure safety and performance of medical devices
|
| gptkbp:applies_to |
medical electrical equipment
home healthcare devices |
| gptkbp:challenges |
small manufacturers
|
| gptkbp:collaborated_with |
research institutions
|
| gptkbp:collaborations |
stakeholders
|
| gptkbp:defines |
usability requirements
|
| gptkbp:focuses_on |
usability
|
| https://www.w3.org/2000/01/rdf-schema#label |
IEC 60601-1-6
|
| gptkbp:includes |
usability testing guidelines
|
| gptkbp:is_adopted_by |
medical device manufacturers
|
| gptkbp:is_aligned_with |
global health standards
|
| gptkbp:is_challenged_by |
emerging technologies
|
| gptkbp:is_cited_in |
gptkb:ISO_13485
|
| gptkbp:is_compatible_with |
gptkb:ISO_14971
|
| gptkbp:is_critical_for |
user satisfaction
device approval process |
| gptkbp:is_designed_for |
end-users
|
| gptkbp:is_discussed_in |
academic literature
|
| gptkbp:is_enhanced_by |
user-centered design principles
|
| gptkbp:is_essential_for |
patient safety
|
| gptkbp:is_evaluated_by |
performance metrics
clinical trials usability experts |
| gptkbp:is_implemented_in |
medical device software
|
| gptkbp:is_influenced_by |
user feedback
|
| gptkbp:is_influential_in |
design standards
|
| gptkbp:is_informed_by |
user experience research
|
| gptkbp:is_integrated_with |
quality management systems
product lifecycle management. |
| gptkbp:is_often_used_in |
healthcare organizations
|
| gptkbp:is_part_of |
compliance documentation
risk management process |
| gptkbp:is_promoted_by |
industry associations
|
| gptkbp:is_referenced_in |
safety assessments
clinical evaluations |
| gptkbp:is_related_to |
gptkb:IEC_62366
|
| gptkbp:is_reviewed_by |
regulatory bodies
technical committees |
| gptkbp:is_subject_to |
regulatory scrutiny
|
| gptkbp:is_supported_by |
gptkb:municipality
training programs |
| gptkbp:is_used_in |
medical device design
|
| gptkbp:is_utilized_in |
product development cycles
|
| gptkbp:part_of |
gptkb:IEC_60601_series
|
| gptkbp:provides |
guidance for manufacturers
|
| gptkbp:published_by |
gptkb:International_Electrotechnical_Commission
|
| gptkbp:published_year |
gptkb:2010
|
| gptkbp:related_to |
human factors engineering
|
| gptkbp:requires |
certain medical devices
|
| gptkbp:title |
Medical electrical equipment -Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability
|
| gptkbp:updates |
gptkb:IEC_60601-1-6:2019
|